JOB SUMMARY This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements JOB RESPONSIBILITIES Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management. May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. Assists with the transfer of deliverables. Performs other work-related duties as assigned. Minimal travel may be required. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. QUALIFICATION REQUIREMENTS Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. Knowledge and experience in the use of SDTM guidelines to build datasets. Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."
22/09/2022
Full time
JOB SUMMARY This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements JOB RESPONSIBILITIES Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management. May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. Assists with the transfer of deliverables. Performs other work-related duties as assigned. Minimal travel may be required. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. QUALIFICATION REQUIREMENTS Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. Knowledge and experience in the use of SDTM guidelines to build datasets. Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."
Senior Clinical Data Scientist Responsible for the end-to-end coordination of cross functional data collection and cleaning activities to ensure clinical study data deliverables are fit for purpose and align with the executed contract and sponsor expectations and timelines. Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities Serves as Functional Lead for Clinical Data Science on complex project with diverse scope, including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups. Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using detailed knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis Works with assigned project teams to communicate, address, troubleshoot and resolve complex data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysis Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables Develops the clinical data acquisition plan and corresponding data flow diagram for complex studies, assess risks associated with protocol design or program level strategies, study set parameters that could impact the credibility and reliability of the trial results within a program of studies. Aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements. Design and drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results. Demonstrates understanding of advanced technology method and the scope of applicability for study or program of studies Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issues Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations Perform metric collection and data analysis to support continuous process improvement Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order Plans, manages, and requests Clinical Data Science resources for assigned projects Coordinates the work of the assigned Clinical Data Science team Develops and maintains project plans, specifications, and documentation in line with SOP requirements Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities Actively promote new clinical data science business opportunities aligned with sponsor strategies. Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities Trains and mentors new or junior team members Maintains proficiency in Clinical Data Science systems and processes through regular training. May attend/represent the company at professional meetings/conferences Performs other work-related duties as assigned. Minimal travel may be required (up to 25%) What we're looking for BA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experience Clinical Data Science experience or an equivalent combination of education and experience Experience in Clinical Data Science practices and relational database management software systems In-depth knowledge of the drug development process and its impact on data quality, in particular riskbased approach, biometrics procedures, workflows. Sound knowledge of analytic modeling methods such as regression, classification and clustering Strong project management skills and knowledge of project management methodologies Strong analytical skills and knowledge of Artificial intelligence /machine learning methodologies preferred Demonstrated staff leadership skills Knowledge of ALCOA+ data quality principles Expertise in protocol interpretation, data collection and data cleaning specification development Experienced with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications Effective oral and written communication and presentation skills Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team Ability to make effective decisions and manage multiple priorities in a highly dynamic environment Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
22/09/2022
Full time
Senior Clinical Data Scientist Responsible for the end-to-end coordination of cross functional data collection and cleaning activities to ensure clinical study data deliverables are fit for purpose and align with the executed contract and sponsor expectations and timelines. Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities Serves as Functional Lead for Clinical Data Science on complex project with diverse scope, including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups. Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using detailed knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis Works with assigned project teams to communicate, address, troubleshoot and resolve complex data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysis Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables Develops the clinical data acquisition plan and corresponding data flow diagram for complex studies, assess risks associated with protocol design or program level strategies, study set parameters that could impact the credibility and reliability of the trial results within a program of studies. Aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements. Design and drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results. Demonstrates understanding of advanced technology method and the scope of applicability for study or program of studies Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve complex data issues Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations Perform metric collection and data analysis to support continuous process improvement Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order Plans, manages, and requests Clinical Data Science resources for assigned projects Coordinates the work of the assigned Clinical Data Science team Develops and maintains project plans, specifications, and documentation in line with SOP requirements Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities Actively promote new clinical data science business opportunities aligned with sponsor strategies. Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities Trains and mentors new or junior team members Maintains proficiency in Clinical Data Science systems and processes through regular training. May attend/represent the company at professional meetings/conferences Performs other work-related duties as assigned. Minimal travel may be required (up to 25%) What we're looking for BA/BS in the biological sciences, computer sciences, mathematics, or data sciences and/or related disciplines in the natural science/health care space. MS degree is preferred. In lieu of degree, equivalent relevant work experience Clinical Data Science experience or an equivalent combination of education and experience Experience in Clinical Data Science practices and relational database management software systems In-depth knowledge of the drug development process and its impact on data quality, in particular riskbased approach, biometrics procedures, workflows. Sound knowledge of analytic modeling methods such as regression, classification and clustering Strong project management skills and knowledge of project management methodologies Strong analytical skills and knowledge of Artificial intelligence /machine learning methodologies preferred Demonstrated staff leadership skills Knowledge of ALCOA+ data quality principles Expertise in protocol interpretation, data collection and data cleaning specification development Experienced with data analysis/data review and visualization tool sets including but not limited to Python, R, Spotfire, SAS Knowledge of medical terminology, clinical data, and ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Sciences Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications Effective oral and written communication and presentation skills Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team Ability to make effective decisions and manage multiple priorities in a highly dynamic environment Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Senior / Principal Statistical Programmer Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required What we're looking for • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. • Experience in mentoring others in clinical trial process and CDISC Standards. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English. Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
22/09/2022
Full time
Senior / Principal Statistical Programmer Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required What we're looking for • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. • Experience in mentoring others in clinical trial process and CDISC Standards. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English. Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
* JOB SUMMARY * Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. F irst level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations. * * * JOB RESPONSIBILITIES * * Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. * Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. * Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. * Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports * Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. * Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. * Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. * Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. * Performs system integration activities, application updates, and user acceptance testing. * Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. * Assists in project meetings and actively contributes and participates in departmental review meetings. * Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. * Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. * Manages project resources, proactively alerting management of delivery and resourcing needs. * Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. *QUALIFICATION REQUIREMENTS * * Bachelor's degree preferred, or equivalent combination of related education and experience. * The ability to deal effectively with sponsors and internal customers at all levels. * Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. * Demonstrated experience in managing multiple priorities in a highly dynamic environment * Experience working in a matrix-structured environment is preferred * Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail * Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. * Ability to travel as necessary (up to 25%) This job excludes Colorado applicants. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
14/09/2021
Full time
* JOB SUMMARY * Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. F irst level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations. * * * JOB RESPONSIBILITIES * * Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. * Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. * Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. * Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports * Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. * Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. * Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. * Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. * Performs system integration activities, application updates, and user acceptance testing. * Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. * Assists in project meetings and actively contributes and participates in departmental review meetings. * Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. * Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. * Manages project resources, proactively alerting management of delivery and resourcing needs. * Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. *QUALIFICATION REQUIREMENTS * * Bachelor's degree preferred, or equivalent combination of related education and experience. * The ability to deal effectively with sponsors and internal customers at all levels. * Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. * Demonstrated experience in managing multiple priorities in a highly dynamic environment * Experience working in a matrix-structured environment is preferred * Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail * Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. * Ability to travel as necessary (up to 25%) This job excludes Colorado applicants. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
*Senior Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • Coordinate the work of the assigned Data Management/Data Operations team • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plan, manages and requests resources for assigned projects • Develop and maintain project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • Trains and mentors data management staff, acts as a subject matter expert • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Clinical data management experience or an equivalent combination of education and experience. • Experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
14/09/2021
Full time
*Senior Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • Coordinate the work of the assigned Data Management/Data Operations team • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plan, manages and requests resources for assigned projects • Develop and maintain project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • Trains and mentors data management staff, acts as a subject matter expert • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Clinical data management experience or an equivalent combination of education and experience. • Experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
*Principal Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) • Development and adherence to standards across a program of projects • Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment • Develops and maintains project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • May participate in or lead Data Management/Operations process improvement initiatives • May supervise/line manage others • Participates in the development of departmental technologies, SOPs, processes, and procedures • Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business • May represent Data Management/Data Operations in company-wide initiatives • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • Progressively responsible work experience in line with the expectations of the role. • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Extensive Clinical data management experience or an equivalent combination of education and experience. • Extensive experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Equal Opportunities Plan> Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.
14/09/2021
Full time
*Principal Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) • Development and adherence to standards across a program of projects • Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment • Develops and maintains project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • May participate in or lead Data Management/Operations process improvement initiatives • May supervise/line manage others • Participates in the development of departmental technologies, SOPs, processes, and procedures • Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business • May represent Data Management/Data Operations in company-wide initiatives • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • Progressively responsible work experience in line with the expectations of the role. • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Extensive Clinical data management experience or an equivalent combination of education and experience. • Extensive experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Equal Opportunities Plan> Its objective is to achieve the principle of equality of opportunity in Syneos Health's employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.
* JOB SUMMARY * This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements * JOB RESPONSIBILITIES * * Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management. * May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Assists with the transfer of deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. * Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. * Excellent written and verbal communication skills. * Ability to read, write, speak, and understand English.
14/09/2021
Full time
* JOB SUMMARY * This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements * JOB RESPONSIBILITIES * * Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management. * May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Assists with the transfer of deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. * Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. * Excellent written and verbal communication skills. * Ability to read, write, speak, and understand English.
*Principal Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) • Development and adherence to standards across a program of projects • Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment • Develops and maintains project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • May participate in or lead Data Management/Operations process improvement initiatives • May supervise/line manage others • Participates in the development of departmental technologies, SOPs, processes, and procedures • Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business • May represent Data Management/Data Operations in company-wide initiatives • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • Progressively responsible work experience in line with the expectations of the role. • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Extensive Clinical data management experience or an equivalent combination of education and experience. • Extensive experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
14/09/2021
Full time
*Principal Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) • Development and adherence to standards across a program of projects • Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment • Develops and maintains project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • May participate in or lead Data Management/Operations process improvement initiatives • May supervise/line manage others • Participates in the development of departmental technologies, SOPs, processes, and procedures • Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business • May represent Data Management/Data Operations in company-wide initiatives • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • Progressively responsible work experience in line with the expectations of the role. • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Extensive Clinical data management experience or an equivalent combination of education and experience. • Extensive experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
*JOB SUMMARY* This position functions as a member of the Biostatistics and Statistical Programming project team serving as a Lead Statistical Programmer for projects of any complexity in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project; assists in managing project budgets and tracking project specific performance metrics; functions as an internal and external customer liaison; provides input to the statistical analysis plan; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets. Demonstrating knowledge of CDSIC (SDTM) and other industry standards / tool and regulatory requirements. *JOB RESPONSIBILITIES* * Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. * Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted. * Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. * Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports. * Supporting project teams in creating SDTM deliverables. * Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. * Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. * Transfers deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. * Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Excellent written and verbal communication skills. * Ability to read, write, speak and understand English.
14/09/2021
Full time
*JOB SUMMARY* This position functions as a member of the Biostatistics and Statistical Programming project team serving as a Lead Statistical Programmer for projects of any complexity in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project; assists in managing project budgets and tracking project specific performance metrics; functions as an internal and external customer liaison; provides input to the statistical analysis plan; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets. Demonstrating knowledge of CDSIC (SDTM) and other industry standards / tool and regulatory requirements. *JOB RESPONSIBILITIES* * Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. * Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted. * Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. * Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports. * Supporting project teams in creating SDTM deliverables. * Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. * Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. * Transfers deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. * Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Excellent written and verbal communication skills. * Ability to read, write, speak and understand English.
* JOB SUMMARY * This position functions as a member of the Biostatistics and Statistical Programming project team serving as a lead statistical programmer or reviewer for any project, especially those of high complexity and scope, or integrated summaries of safety/efficacy for submission, in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project or across a program or submission; manages project budgets and tracks project specific performance metrics; functions as an internal and external customer liaison; provides input to statistical analysis plans; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets . A Principal Statistical programmer demonstrating a high degree of expertise of CDSIC (SDTM) and other industry standards / tool and regulatory requirements may serves as a subject matter experts leading innovations and providing guidance to the Biostatistics Department. * JOB RESPONSIBILITIES * * Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Accountable for on- time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. * Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. * Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports. * Supporting project teams in creating SDTM deliverables. * Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. * Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. * Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. * Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. * Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. * When serving as a technical subject matter expert for CDSIC(SDTM) and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDSIC(SDTM) Standards * When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML). * When serving as a subject matter expert for CDSIC (SDTM) and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. * Transfers deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. * Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. * Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Experience in submissions to a regulatory agency preferred. * Experience in mentoring others in clinical trial process and CDSIC (SDTM) Standards. * Excellent written and verbal communication skills. * Ability to read, write, speak and understand English.
14/09/2021
Full time
* JOB SUMMARY * This position functions as a member of the Biostatistics and Statistical Programming project team serving as a lead statistical programmer or reviewer for any project, especially those of high complexity and scope, or integrated summaries of safety/efficacy for submission, in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project or across a program or submission; manages project budgets and tracks project specific performance metrics; functions as an internal and external customer liaison; provides input to statistical analysis plans; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets . A Principal Statistical programmer demonstrating a high degree of expertise of CDSIC (SDTM) and other industry standards / tool and regulatory requirements may serves as a subject matter experts leading innovations and providing guidance to the Biostatistics Department. * JOB RESPONSIBILITIES * * Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Accountable for on- time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. * Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. * Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports. * Supporting project teams in creating SDTM deliverables. * Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. * Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. * Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. * Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. * Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. * When serving as a technical subject matter expert for CDSIC(SDTM) and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDSIC(SDTM) Standards * When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML). * When serving as a subject matter expert for CDSIC (SDTM) and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. * Transfers deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. * Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. * Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Experience in submissions to a regulatory agency preferred. * Experience in mentoring others in clinical trial process and CDSIC (SDTM) Standards. * Excellent written and verbal communication skills. * Ability to read, write, speak and understand English.
*Principal Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) • Development and adherence to standards across a program of projects • Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment • Develops and maintains project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • May participate in or lead Data Management/Operations process improvement initiatives • May supervise/line manage others • Participates in the development of departmental technologies, SOPs, processes, and procedures • Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business • May represent Data Management/Data Operations in company-wide initiatives • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • Progressively responsible work experience in line with the expectations of the role. • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Extensive Clinical data management experience or an equivalent combination of education and experience. • Extensive experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
14/09/2021
Full time
*Principal Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) • Development and adherence to standards across a program of projects • Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment • Develops and maintains project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • May participate in or lead Data Management/Operations process improvement initiatives • May supervise/line manage others • Participates in the development of departmental technologies, SOPs, processes, and procedures • Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business • May represent Data Management/Data Operations in company-wide initiatives • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • Progressively responsible work experience in line with the expectations of the role. • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Extensive Clinical data management experience or an equivalent combination of education and experience. • Extensive experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
*Principal Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) • Development and adherence to standards across a program of projects • Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment • Develops and maintains project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • May participate in or lead Data Management/Operations process improvement initiatives • May supervise/line manage others • Participates in the development of departmental technologies, SOPs, processes, and procedures • Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business • May represent Data Management/Data Operations in company-wide initiatives • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • Progressively responsible work experience in line with the expectations of the role. • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Extensive Clinical data management experience or an equivalent combination of education and experience. • Extensive experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
14/09/2021
Full time
*Principal Project Data Manager* Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. *Why Syneos Health* • #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. *Job responsibilities * • On a stand-alone project acts as Project Leader, including primary Sponsor contact for all contracted Data Management activities and deliverables. On a full service project acts as Functional Lead for Data Management including primary contact for internal liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional groups • May take on a primary oversight/liaison role for a program/partnership including representation on governance committees and input to the Partnership Operating Manual (POM) • Development and adherence to standards across a program of projects • Coordinate the work of the assigned Data Management/Data Operations team including PDMs assigned to projects within the program • Ensures launch, delivery and completion of all Data Management activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations • Provides project specific training to internal and external audiences as required • Responsible for financial management of assigned projects / programs, including revenue recognition, changes in scope and participation in internal project review meetings, including liaison with Finance and Contracts groups as needed • Monitors and communicates project/program progress to the Sponsor and project team including use of project status reports and tracking tools/metrics to enable in stream data collection and query management • Supports the management of resources on assigned projects/programs • Plans, manages and requests resources for assigned projects / programs supporting PDMs on a program to plan for most efficient resource assignment • Develops and maintains project plans, specifications and documentation in line with SOP requirements • Maintains documentation on an ongoing basis and ensures that all TMF filing is correct and up to date • Participates in, and presents at internal, Sponsor, third-party, and investigator meetings • Plans for and creates necessary documentation to support internal and external audits; participates in such audits • May participate in or lead Data Management/Operations process improvement initiatives • May supervise/line manage others • Participates in the development of departmental technologies, SOPs, processes, and procedures • Trains and mentors data management staff, acts as a subject matter expert. Develops and delivers applicable data management departmental training. • Prepares input for, and participates in proposal bid defense meetings • Maintains proficiency in Data Management systems and processes through regular training. May attend/represent the company at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business • May represent Data Management/Data Operations in company-wide initiatives • Performs other work related duties as assigned. Minimal travel may be required (up to 25%)*What we're looking for* • Progressively responsible work experience in line with the expectations of the role. • BA/BS in the biological sciences or related disciplines in the natural science/health care field or Registered Nurse. In lieu of degree, equivalent relevant work experience. • Extensive Clinical data management experience or an equivalent combination of education and experience. • Extensive experience in Clinical Data Management practices and relational database management software systems. • Strong project management skills and knowledge of project management methodologies • Demonstrated staff leadership skills. • Contract Research Organization (CRO) experience preferred. • Direct exposure to Oracle Clinical, Rave, or Inform systems. Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practices. • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications. • Effective oral and written communication skills. • Strong presentation skills • Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail. • Ability to be flexible and adapt to change, to work independently, as well as part of a multi-disciplinary team. • Ability to make effective decisions and manage multiple priorities in a highly dynamic environment. • Extensive knowledge of ICH/GCP regulatory requirements for clinical studies, in particular requirements applicable to Clinical Data Management *Get to know Syneos Health* We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. *Additional Information:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Jobs - Frequently Asked Questions
Use the location filter to find IT jobs in cities like London, Manchester, Birmingham, and across the UK.
Entry-level roles include IT support technician, junior developer, QA tester, and helpdesk analyst.
New jobs are posted daily. Set up alerts to be notified as soon as new roles match your preferences.
Key skills include problem-solving, coding, cloud computing, networking, and familiarity with tools like AWS or SQL.
Yes, many employers offer training or junior roles. Focus on building a strong CV with relevant coursework or personal projects.
